Lyme Disease Vaccine on Fast Track for FDA Approval

The U.S. Food and Drug Administration (FDA) this week announced plans to expedite approval of a vaccine for Lyme disease. Valneva, the maker of the vaccine candidate, known as VLA15, recently completed an initial evaluation in a small, early stage clinical trial. Now the company has been given a green light by the regulatory agency through a program known as Fast Track to move onto a larger trial at the beginning of 2018. Additionally it will announce findings from the first trial around the same time. The designation could reduce the amount of time required for developing the vaccine by several years. With crucial agents that are fast-tracked, the FDA will accept less data and studies can be completed after approval.

The Phase 1 trial for VLA15, meant to evaluate the safety and efficacy of the vaccine, is ongoing at three sites on a total of 180 subjects aged 18 to 40. Two study sites are located in the U.S. and the third is in Belgium. The study is “observer blind,” meaning researchers are unaware of the dosages administered to participants.

There is currently no vaccine to protect against Lyme disease. The U.S. Centers for Disease Control and Prevention (CDC) says that Lyme disease is the fastest growing vector-borne infection in the U.S. According to the CDC, there were nearly 29,000 confirmed cases and nearly 10,000 probable cases in 2015 nationwide. Comparatively, a decade ago—in 2005—health officials reported a little over 23,000 cases in the U.S.

There is a long history of efforts to immunize against Lyme disease. For a number of years, a contingent of anti-vaxxers (people who believe vaccines are harmful and cause autism and other health problems) have tried to slow down the approval of a Lyme disease vaccine. In the 1990s, SmithKline Beecham, a large pharmaceutical company, received FDA approval for its vaccine called LYMErix. But this vaccine was later withdrawn from the market after concerns that it caused arthritis. A group of 121 individuals filed a class action lawsuit in 1999. The lawsuit claimed the pharmaceutical company was hiding evidence of the vaccine’s harmful side effects. The company settled the suit in 2003. The plaintiffs didn’t receive any compensation because their attorney said SmithKline Beecham’s voluntary removal of LYMErix from the market was sufficient enough.

Lyme disease (Borrelia burgdorferi) is a bacteria carried by ticks. Humans become infected when they are bitten by an infected tick. Symptoms of an infection include fever, fatigue, achy joints, headache and a telltale bulls-eye shaped rash at site of the bite. Once diagnosed, Lyme disease can be treated with a course of antibiotics. However, some patients report that symptoms of the illness can linger long after the acute infection is cleared up, what’s known as post-treatment Lyme disease syndrome (PTLDS). However, many experts say there isn’t currently enough evidence to prove that PTLDS is a pathology that actually exists.

The vaccine candidate targets the protein in the Lyme disease bacteria, known as the Outer Surface Protein A (OspA). OspA is one of the most dominant proteins when it becomes infected with B. burgdorferi. The company, a biotech firm in Europe, produces commercial vaccines for travelers that include one to prevent against Japanese encephalitis and another for cholera. Whether and when the Lyme disease vaccine could be approved is uncertain. But the FDA’s Fast Track designation indicates that the need is critical, now more than ever.